Description
A lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens via nasopharyngeal swab and oropharyngeal swab from individuals who have been deemed by healthcare professionals as potential carriers of COVID-19.
It is based on the standard Double-Antibody-Sandwich (DAS-ELISA) method.
If the sample contains the SARS-CoV-2 antigen, the test line (T) will appear colored in the corresponding result area.
The absence of the test line suggests a negative result instead.
The control line (C) is used for procedural control, and should always appear colored if the test is performed correctly.

Instructions for use
Samples can be collected via nasopharyngeal swab and oropharyngeal swab.
For nasopharyngeal swab, place the extraction tube on the workstation. Add all the extraction reagent into the extraction tube.
Tilt the patient's head back about 70 degrees. Insert the sterile swab through the nostril parallel to the palate. Gently rub and rotate the swab, and leave the swab in place for a few seconds to allow absorption of nasal secretions. Slowly remove the swab while rotating it.
Insert the swab into the extraction tube. Rotate the swab at least 5 times and leave the swab in the extraction tube for one minute. Securely cap the extraction tube with the dropper. Transfer 3 drops (approximately 100 mcL) into the sample well of the test device.
Read results after 15 minutes. Do not read results after 20 minutes.

Warnings
Components are for single use: do not reuse.
Do not use if the packaging is not intact.
Inadequate sample collection, improper handling and/or transport can lead to false results; therefore, training on sample collection is highly recommended given the importance of sample quality to obtain accurate test results.

Storage
Store at a temperature ranging from 4 °C to 30 °C.
Shelf life in unopened packaging: 24 months.

Format
The kit contains:
- 25 test cassettes;
- 25 extraction tubes;
- 25 sterilized swabs;
- 1 workstation;
- 25 extraction reagents;
- 25 droppers;
- 1 leaflet.

Code. 101125